Background: Currently, there is renewed interest in the role
community participation can play in Primary Health Care (PHC) programmes such
as the delivery of effective anti-TB treatment to patients in high-burden
settings. Objectives:To explore the feasibility of community participation
in a high-burden Tuberculosis Control Programme and to establish how
supervision of treatment by lay volunteers compares with other methods of
tuberculosis treatment delivery in the Northern Cape province of South
Africa.
Methods: Prospective study involving 769 patients with confirmed
pulmonary TB who were followed-up over a one-year period. Questionnaire
interviews were also carried out with 135 lay volunteers participating in the
TB programme. Results: One-third of the TB patients in the study received
their treatment from lay volunteers in the community. Treatment outcomes for
new patients supervised from the community were found to be equivalent to
those who received treatment through other modes of treatment delivery
(RR=1.04[0.94-1.16], p=0.435). For the re-treatment patients, community-based
treatment was found to be superior (RR=5.89[2.30-15.09], p<0.001), to
self-administered therapy. Conclusions: Health care planners should consider community
participation as a viable way of ensuring accessibility and effectiveness in
PHC programmes. There is need for more research into ways of achieving
sustainability in resource-limited but high disease burden settings.

Community participation in health is a complex entity that has been
extensively examined by a number of authors and continues to be of great
interest even today.1-6 The genesis of the idea and its conceptual
development are primarily attributed to large multinational organizations
particularly the World Health Organization (WHO).6 This paper
seeks to examine the concept of community participation in primary health
care (PHC) activities with particular reference to tuberculosis (TB)
control.

TB remains a global problem today despite the fact that effective
treatment has been available for over 50 years.7 The greatest
burden of the disease is in resource-limited, developing countries where the
close association between TB and the HIV epidemic has resulted in an
exponential rise in the number of TB cases seen over the past two
decades.8-9

Poor patient adherence to prescribed medication has been recognised as one
of the major hindrances to effective TB control.10 In response to
this problem, the WHO Global Programme on Tuberculosis advocates for the use
of Directly Observed Treatment (DOT) for all patients.11 While
this approach results in improved cure rates,12-14 it is also
labour intensive and over burdened health staff in high incidence areas often
find it a daunting task to have to administer DOT to the large numbers of TB
patients they see daily.15

Innovations with DOT have resulted in development of community-based TB
treatment delivery whereby patients are offered ambulatory treatment at home.
The need for community participation in TB control activities is not new: it
was well recognised in the Ninth Report of the WHO Expert Committee on
Tuberculosis in 1974.16 A decade earlier, the WHO had recognised
the need to incorporate TB control into a comprehensive countrywide system,
which is permanent, adapted to the needs of the population and integrated
into the primary health care system.17

Today, the reality however is that in many developing countries,
government services still reach only a proportion of the population. Some
authors,18,19 think this is because of the limitations imposed by
an inadequate health service infrastructure, an insufficient level of
decentralization to ensure adequate access to health care, and a paucity of
locally available human and financial resources.

Community participation in TB treatment delivery, as part of routine
National Tuberculosis Programme activities has the potential to overcome at
least some of these limitations. An ad-hoc Expert committee on Tuberculosis
convened by WHO in 1998 concluded that “community involvement in TB
care and a patient-centred approach need emphasis and promotion.”
20 Harnessing participation by the community could dramatically
expand the provision of effective ambulatory TB treatment delivery and result
in more widespread implementation of the internationally recommended Directly
Observed Treatment – Short Course (DOTS) TB control strategy.

It is important to note, however, that until relatively recently, the
focus of activities aimed at strengthening TB services in high incidence
countries have been more towards improving the general health services rather
than on harnessing community participation.18 It is the dramatic
increase in the TB burden related to the HIV/AIDS epidemic in many countries
in sub-Saharan Africa that has prompted fresh interest in evaluating the
potential of local communities to contribute to TB care in this region and
elsewhere.

Achieving community participation in health service delivery in
resource-limited but a high disease burden setting is not a simple task. Here
the perception of the general population is often that of a grossly
inefficient formal health sector that has simply failed to deliver.
Additionally, community members may seek remuneration for participation in
health service delivery, a stance that is not often sustainable in poorly
resourced developing countries. Alternatively, health service personnel may
not be willing to involve laypersons in the execution of health programmes,
an act that they may view as a dilution of their own expertise.

This paper explores the feasibility of community participation in a
high-burden TB programme in a resource-limited setting and attempts to
establish how supervision of TB treatment by lay volunteers compares with
other methods of TB treatment delivery in the Northern Cape province of South
Africa.

METHODS

Setting

This study was conducted in the Northern Cape province, Republic of South
Africa. South Africa is one of the 22 countries with the highest burden of
tuberculosis in the world.21 The Northern Cape is the largest
province in South Africa and had an estimated TB incidence of 547 cases per
100 000 population in 2000.22

ORGANIZATION OF TB SERVICES

The introduction of a District Health Service (DHS) system in South Africa
after 1994 meant that the responsibility of TB treatment was largely devolved
to Primary Health Care units.23 Additionally, there has been a
drive towards involving the community and non-governmental organizations
(NGOs) in the National TB Control Programme. The aim is to recruit lay
volunteers from the community to directly observe TB patients as they take
their treatment.24

In 1997, the Northern Cape province adopted the guidelines of the
WHO-recommended DOTS strategy for TB treatment. Direct Observation of
treatment for TB patients (DOT) is one of the key components of this
strategy. In order to achieve this, the TB programme in the Northern Cape
province involves the participation of three major role players namely: the
formal health services, NGOs and the community.

Treatment for uncomplicated pulmonary tuberculosis is ambulatory and is
largely provided through Primary Health Care clinics, which are all managed
under either the municipal or provincial governments. Treatment at these
clinics is provided free of charge. NGOs participate in the TB programme by
providing facilitation and training on community-based DOT provision to
clinic staff and lay volunteers. The community provides nonpaid volunteers
who act as DOT supporters for the TB patients during the whole duration of
treatment.

TB TREATMENT DELIVERY OPTIONS

After diagnosis of TB through sputum smear microscopy, the new case is
then registered at the clinic and the attending nurse discusses the treatment
options available with the patient.

The patient is normally given the options of clinic or community-based DOT
and told to make a choice between these two with the advise of the clinic
nurse. The choice of self-administered therapy (SAT) is also available to
those patients who are unable to take up the supervised options.

Clinic-based DOT

Patients who opt for clinic-based DOT are asked to come to the clinic five
days a week to be observed by the clinic nurse as they swallow their tablets.
Nurses administering DOT at the clinic usually follow a set routine: patients
are asked to fill a disposable cup with clean water, anti-TB tablets are
dispensed into a small plastic cup and patients swallow their medication
under the watchful eye of the nurse who then records their attendance and
compliance on the patient treatment card.

Community-based DOT

Patients who opt for community-based DOT are assigned to a lay volunteer
[DOT supporter] who is attached to that clinic and lives within reasonable
proximity from the patient. The patient and DOT supporter then meet and work
out the modalities of when it is convenient to supervise treatment for each
day. DOT supporters are given secure boxes at the clinic in which to store
the patients’ drugs and are trained on how to administer and record TB
treatment. Each DOT supporter can supervise up to 4 TB patients at any one
time, for the duration of their treatment. The clinic nurse in charge of TB
supervises the volunteers who normally return to the clinic every fortnight
in order to replenish their supply of drugs and report any problems they may
have encountered. Additionally, DOT supporters are expected to follow-up
absent patients after one skip, remind patients of clinic appointments, and
to refer those TB patients with other problems to the relevant services. DOT
supporters do not receive any remuneration for providing these services.

Self-administered therapy

Patients receiving this option are given a monthly supply of anti-TB drugs
to take home with them. They are also given a patient treatment card to
record their compliance. These patients report to the clinic at monthly
intervals to replenish their drug supply and to be evaluated.

Regimens

Short course chemotherapy is used for the treatment of uncomplicated
pulmonary TB in the Northern Cape province. Treatment is provided 5 days per
week and new patients are treated for 6 months while re-treatment patients
receive treatment for 8 months. Drug dosages are calculated according to
patient weight, which for adult patients is divided into 2 categories with a
cut-off weight of 50 kilogrammes.

Re-treatment patients normally receive the first two months of the
intensive phase of treatment at the clinic, as they have to get their daily
streptomycin injections during this phase. New patients can start off with
the supervision option of their choice as soon as they have been
diagnosed.

DATA COLLECTION

This study was conducted during the period from October 1999 to October
2000. A prospective study involving patients with proven pulmonary TB who
were started on anti-TB treatment within the first five months of the study
period was undertaken. Patients who participated in the study were recruited
from 45 Primary Health Care facilities in the Northern Cape province.
Participating facilities were randomly selected from a sampling frame of 80
fixed clinics and day hospitals after secondary and tertiary health units had
been excluded.

Sample size estimation

The total number of new TB patients to be followed up during the study
period was estimated as follows:

n = number of patients required for follow-up.r = number of patients who opt for community based TB treatment
supervision. p= proportion of patients who opt for community based TB treatment
supervision.
Hence; p = r/n

We estimated this proportion of patients to be 0.5, Therefore, the
confidence interval width, w at 95% level of confidence was calculated
as:

Hence rearranging the equation to obtain the value of n:

Setting p=0.5 and w = 0.05 for the above equation; n was calculated as
384.

We took into consideration the observation that the treatment interruption
rate in the Northern Cape Province during 1998 was about 19%. We therefore
anticipated a total of 460 patients to be followed up at the selected clinics
in the study.

In order to achieve the estimated sample size, all patients who fitted the
selection criteria below in the selected clinics were approached to
participate in this study.

New TB patients who started treatment during the months of October 1999
– February 2000 inclusive

Re-treatment TB patients who started treatment in the months of
November 1999 and February 2000

TB patients who were ordinarily residents of the regions where the
study took place

At the end of the 5-month recruitment phase, 769 patients fitting the
selection criteria had accepted to participate in the study.

DOT supporters supervising TB patients registered at 30 of the selected
facilities were also interviewed as part of the study. Random sampling was
achieved by use of a computer algorithm in SPSS 9.0 Statistical Package (SPSS
Inc., Chicago, IL).

Data collection involved the administration of a largely pre-coded
interviewer-administered questionnaire to eligible study participants [one
for both patients and DOT supporters]. The structured questionnaires used in
this study were developed with the help of staff from the provincial TB
management unit and a specialist scientist from the Tuberculosis Research
Programme of the Medical Research Council of South Africa. Initial drafts of
the questionnaires were piloted to determine the most appropriate wording and
structuring.

The questionnaires were translated into Afrikaans. The Afrikaans versions
were then back translated into English by an independent person in order to
determine whether the translated versions were similar to the original
version and conveyed the questions the study sought to ask.

Consent was sought from each study participant before interview and for
the patient interviews, only subjects of age 15 years and above were eligible
to participate in the study. Subsequent followup of the TB patients was done
through regular visits to the participating health facilities to collect
information recorded about each study subject from the formal health
records.

This paper reports only issues pertaining to community participation in TB
treatment delivery programme in the Northern Cape province. Other aspects of
the TB programme that were explored in the interviews have been described
elsewhere.25,26

The study received ethical approval from the Department of Health,
Northern Cape province.

Analysis

Data were entered into a portable computer, statistical analysis was done
mainly using Epi Info 2000 version 1.0 (CDC, Atlanta, GA). Univariate
analysis was done separately for new and re-treatment patient cohorts as
recommended by WHO guidelines.27 The relative risk (RR) estimate
and the Chi-squared test were used to analyse associations between variables.
For this study, “statistically significant” was measured at the
0.05 level.

RESULTS

769 patients with confirmed pulmonary tuberculosis were recruited
for this study. The general characteristics of these patients are summarised
in Table 1

Table 1 shows that
71(9.2%) of the patients in this study were not interviewed. This was because
these patients had transferred to a different region, defaulted from
treatment or died by the time of the interviews. Outcomes for these patients
where however obtained from the formal health records.

Fifty patients (6.5%) transferred to health facilities outside the study
region. The treatment outcome of these patients was therefore indeterminable
and hence they were excluded from further analysis. Of the remaining
patients, 598 (83%) were new patients and 121 (17%) were re-treatment
patients.

Only 54% (65/121) of re-treatment patients had a successful treatment
outcome compared to 70% (419/ 598) of new patients. This difference was found
to be statistically significant (p<0.001).

Overall, more than one-third of the patients chose community-based
treatment supervision as their mode of TB treatment delivery. Table 2 shows
the treatment outcome of both new and re-treatment patients according to
choice of treatment delivery. It can be seen that there is no significant
difference between community-based treatment supervision and the other
options available for new patients. For the re-treatment patients however,
communitybased supervision was found to be superior to self-administered
therapy (c2= 22.76, p<0.001).

Table 3 shows the general characteristics of the DOT Supporters who were
interviewed in this study.

Table 3 shows that almost 93% of the DOT supporters were female,
this contrasted sharply with the sex distribution of the TB patients in the
study, where only 41% where female (χ2=120.65, p<0.001). 70% of
DOT supporters were less than 45 years of age, which was almost similar to
the number of TB patients in the study who were below 45 years of age
(χ2= 0.86, p=0.355).

The occupation status of DOT supporters and TB patients in the study was
found to be similar as shown in Figure 1.

The majority of study participants in each case were found to be
unemployed. The trend for ducation status however, differed between the
patients and DOT supporters. A Chi-squared test for linear trend done between
DOT supporters and TB patients in the study showed that the DOT supporters
were significantly more educated than the TB patients (χ2=60.37, p<0.001).
This trend is graphically represented by Figure 2.

DISCUSSION

This study explored the role lay community members can play in a TB
programme run at the Primary Health Care level in a high-burden but
resource-limited setting. Onethird of the TB patients in this study were
found to receive their treatment from DOT supporters in the community.

The finding that community-based DOT produced outcomes that were
equivalent to the other treatment options for new patients and was superior
to selfadministration of drugs for re-treatment patients suggests that lay
volunteers can effectively dispense anti-TB medication and community
participation should be encouraged.

The implication of this in high TB burden settings is that community-based
TB treatment is an effective and viable option that can supplement other
modes of treatment delivery. Furthermore, community-based TB treatment
delivery has been found to be cost-effective,28 and it is a low
cost technology that can easily be adapted to diverse areas of need and
appropriate lay volunteers recruited according to availability in each
contextual setting.

Additionally, community participation in health can be extended to involve
other high-burden diseases, notably HIV/AIDS. The World Health Organization
currently advocates for the home-based care and integrated management of
dually infected TB/AIDS patients. DOT supporters can be further trained to
carry out this additional task and pilot studies are underway to evaluate the
feasibility of this approach.22

A major hindrance to community participation in developing countries is
the desire for remuneration by the lay volunteers. There is evidence to
suggest that in the absence of appropriate incentives, attrition rates in lay
worker programmes tend to be high after the initial novelty wears
off.26 Economic realities in developing countries often dictate
that people expect some kind of remuneration for work done. As this study
reveals, TB patients and those who volunteered to support them during their
treatment often come from the same socio-economic background and in areas
where unemployment is high, expectation of payment for any kind of work
performed is also high.

In the Northern Cape province, the combination of young, reasonably well
educated but unemployed DOT supporters in the TB programme posed a serious
threat to the sustainability of the programme because volunteers started to
drop out as soon as they realised that they would not be paid for their work.
This study also revealed that the majority of lay participants in the TB
programme in the Northern Cape province were female, similar findings have
been reported in Community Health Worker programmes elsewhere29
and is perhaps a reflection of the fact that in many developing countries,
women tend to stay at home [and hence can volunteer for health programmes]
whilst the men are expected to go off to look for work to support the
family.

The onus is on health planners to devise appropriate and context-specific
ways in which to achieve sustainability by keeping lay people motivated in
community participation in health programmes while at the same time keeping
in mind the limitations of cost-containment. More research is required on
exactly how this can be achieved in specific settings with a high burden of
disease.

ACKNOWLEDGEMENTS

The authors would like to thank all the patients and DOT supporters
who participated in this study. Financial assistance for this study was
obtained through grants from the Sir Halley Stewart Trust and the Department
for International Development, UK and is gratefully acknowledged.

REFERENCES

Muller F. Participation in Primary Health Care Programmes in
Latin America. University of Antioquia, National School of Public Health.
Medillin: Colombia, 1980.

Oakley P. Community Involvement in Health Development: An examination
of the critical issues. Geneva: WHO, 1989.